Hemodialysis 510k Submission Support

MEDICAL SYSTEM:

Hemodialysis System

WORK SCOPE:

Systems engineering activities including leading risk management activities, creating system specifications aligned with system requirements and user needs, sub-systems specifications aligned with design inputs and architecture, and completion of Risk Management files.

  1. Lead risk management activities:
    • Review existing Fault Tree Analysis (top-down Hazard Analysis)
    • Determine specific alarm limits/delays to meet HA requirements
    • Create process and template for design FMEAs
  2. Lead engineering activities for usability / HFE:
    • Review and complete use cases
    • Lead uFMEA (w/ outside usability team)
    • Lead creation of Usability Specification
  3. Manage creation and review of System Specification, Subsystem Specifications, and Test Procedures
  4. Other Systems Engineering tasks (requirements alignment / structuring, algorithm / design input to SW, etc.)

BACKGROUND:

The company is a leading manufacturer of advanced dialysis machines for patients suffering from chronic or acute kidney failure. To maintain its leadership the company is pursuing two new product introductions to expand to the home markets and next-generation critical care environments.

The quality management system and product development procedures needed updates to comply with design controls and patient data security regulations as per 21 CFR 820.30 and 21 CFR Part 11. In addition various areas in the project technical design history file required updating to ensure consistency with other project data (e.g. RMF, legacy products). There were also new hires being added to the engineering team and high level design documentation (e.g. system architecture, design input requirements, etc.) was inadequate to help ramp up the new team members efficiently.

RESULTS:

Developed standard operating procedures for design and usability FMEA and software hazard analysis, and aligned with other existing risk management procedures. Aligned risk assessment procedures with ISO 14971:2012, FDA guidances and best practices. Engaged with cross discipline technical leads and conducted system design and software risk assessment working sessions to identify failures, root causes, effects, hazardous situations and harms, and corresponding design/process/labeling risk controls. Created design input requirements for risk mitigations identified, and allocated to appropriate technical disciplines negotiating requirements with electrical, software and mechanical team owners. Developed safety and performance regulatory compliance requirements and aligned with the system/subsystem design input requirements per IEC 60601-1, its collaterals and particulars. Reviewed FDA submission guidances related to hemodialysis equipment, then reviewed international standards clause-by-clause to identify applicable requirements and provide justifications for requirements that do not apply. Created draft traceability data and Risk Management Summary report aligned with RMF artifacts to support the 510k submission.

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